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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 18 USDMF, 5 CEP/COS, 6 EU WC, 4 KDMF, 23 NDC API, 16 Listed Suppliers, $ API Reference Price

29 API Suppliers
18 USDMF
5 CEP/COS
6 EU WC
4 KDMF
23 NDC API
16 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

217 FDF Dossiers, 145 FDA Orange Book, 37 Europe, 11 Canada, 6 South Africa, 18 Listed Dossiers

217 FDF Dossiers
145 FDA Orange Book
37 Europe
11 Canada
6 South Africa
18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 10MG/5ML, INJECTABLE;INJECTION - 25MG/ML, INJECTABLE;INJECTION - 50MG/ML, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG

drugProductComposition
INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SYRUP;ORAL - 10MG/5ML
INJECTABLE;INJECTION - 25MG/ML
INJECTABLE;INJECTION - 50MG/ML
TABLET;ORAL - 25MG
TABLET;ORAL - 50MG

DIGITAL CONTENT

8 NEWS #PharmaBuzz

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8 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

32 Finished Drug Prices

globalSalesInformation
32 Finished Drug Prices

MARKET PLACE

9 APIs, 3 FDF Dossiers

marketPlace
9 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 2 USP , 1 Others

otherSolutions
1 EDQM
2 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 152

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

217

FDF Dossiers

145

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Hydroxyzine hcl, 1244-76-4, Hydroxyzine monohydrochloride, Ca67jf5q4w, Mls000028602, Smr000058737

Molecular Formula

C₂₁H₂₈Cl₂N₂O₂

Molecular Weight

411.4 g/mol

InChI Key

IPSVAUIEEPSJRZ-UHFFFAOYSA-N

FDA UNII

CA67JF5Q4W

A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.

1 2D Structure

Hydroxyzine Dihydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol;hydrochloride

2.1.2 InChI

InChI=1S/C21H27ClN2O2.ClH/c22-20-8-6-19(7-9-20)21(18-4-2-1-3-5-18)24-12-10-23(11-13-24)14-16-26-17-15-25;/h1-9,21,25H,10-17H2;1H

2.1.3 InChI Key

IPSVAUIEEPSJRZ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CN(CCN1CCOCCO)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl.Cl

2.2 Other Identifiers

2.2.1 UNII

CA67JF5Q4W

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)ethanol

2. Atarax

3. Durrax

4. Hydroxyzine

5. Hydroxyzine Dihydrochloride

6. Hydroxyzine Pamoate

7. Orgatrax

8. Pamoate, Hydroxyzine

9. Vistaril

2.3.2 Depositor-Supplied Synonyms

1. Hydroxyzine Hcl

2. 1244-76-4

3. Hydroxyzine Monohydrochloride

4. Ca67jf5q4w

5. Mls000028602

6. Smr000058737

7. 2-(2-(4-((4-chlorophenyl)phenylmethyl)piperazin-1-yl)ethoxy)ethanol Hydrochloride

8. 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol;hydrochloride

9. 2-[2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]ethanol Hydrochloride

10. Einecs 214-989-3

11. Unii-ca67jf5q4w

12. Hydroxyzin Hydrochloride

13. Opera_id_1515

14. 1-(p-chlorobenzhydryl)-4-(2-(2-hydroxyethoxy)ethyl)diethylenediamine Hydrochloride

15. Dsstox_cid_27530

16. Dsstox_rid_82400

17. Dsstox_gsid_47530

18. Schembl41448

19. Mls002222192

20. Chembl1201007

21. Dtxsid5047530

22. Tox21_302563

23. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Monohydrochloride

24. Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, Hydrochloride

25. Ethanol, 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)-, Monohydrochloride

26. Ncgc00180974-01

27. Ncgc00256629-01

28. 14729-22-7

29. Cas-1244-76-4

30. Q27275377

31. 2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol;hydron;chloride

32. 2-[2-[4-[(4-chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]ethanolhydrochloride

33. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Hydrochloride (1:1)

34. Ethanol, 2-(2-(4-(p-chloro-.alpha.-phenylbenzyl)-1-piperazinyl)ethoxy)-, Monohydrochloride

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₈Cl₂N₂O₂
Molecular Weight	411.4 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	8
Exact Mass	410.1527835 g/mol
Monoisotopic Mass	410.1527835 g/mol
Topological Polar Surface Area	35.9 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	376
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

Antipruritics

Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

4.2 FDA Pharmacological Classification

4.2.1 Pharmacological Classes

Histamine Receptor Antagonists [MoA]; Antihistamine [EPC]

API SUPPLIERS

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USDMF

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CEP/COS

01

FLEMING LABORATORIES LIMITED Nawabp...

India

AES 2024

Not Confirmed

02

GLOCHEM INDUSTRIES PRIVATE LIMITED ...

India

AES 2024

Not Confirmed

03

IPCA LABORATORIES LIMITED Mumbai IN

India

AES 2024

Not Confirmed

04

KREATIVE ORGANICS PRIVATE LIMITED H...

India

AES 2024

Not Confirmed

05

SYMED LABS LIMITED Hyderabad IN

India

AES 2024

Not Confirmed

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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HEALTHCARE","customerCountry":"INDIA","quantity":"1996.00","actualQuantity":"1996","unit":"KGS","unitRateFc":"200","totalValueFC":"403124","currency":"USD","unitRateINR":"16860","date":"25-Jun-2024","totalValueINR":"33652560","totalValueInUsd":"403124","indian_port":"SEZ\/Mahaboobnagar","hs_no":"29335990","bill_no":"1002054","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"VIA COLLEONI, 15\/17-24040 CISERANO( BG) Italy","customerAddress":"3RD FLOOR, PLOT NO.2, MAITRIVIHAR,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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FDF Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INJECTION - 25MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 11111

DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Fed...DOSAGE - INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 11111

DOSAGE - SYRUP;ORAL - 10MG/5ML

USFDA APPLICATION NUMBER - 87294

DOSAGE - INJECTABLE;INJECTION - 25MG/ML

USFDA APPLICATION NUMBER - 87408

DOSAGE - INJECTABLE;INJECTION - 50MG/ML

USFDA APPLICATION NUMBER - 87408

DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 88618

DOSAGE - TABLET;ORAL - 50MG

USFDA APPLICATION NUMBER - 88619

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers

18 USDMF

5 CEP/COS

6 EU WC

4 KDMF

23 NDC API

16 Listed Suppliers

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FINISHED DOSAGE FORMULATIONS

217 FDF Dossiers

145 FDA Orange Book

37 Europe

11 Canada

6 South Africa

18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SYRUP;ORAL - 10MG/5ML

INJECTABLE;INJECTION - 25MG/ML

INJECTABLE;INJECTION - 50MG/ML

TABLET;ORAL - 25MG

TABLET;ORAL - 50MG

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3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM

2 USP

1 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 152

MARKET PLACE

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PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

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CEP 2021-436 - Rev 00

Valid

Chemical

2024-10-08

916

01

CEP 2022-318 - Rev 00

Valid

Chemical

2024-06-05

916

02

CEP 2010-076 - Rev 03

Valid

Chemical

2024-09-11

916

03

CEP 2016-056 - Rev 01

Valid

Chemical

2024-10-16

916

04

R1-CEP 2015-186 - Rev 00

Valid

INJECTABLE;INJECTION - 25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - 50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons